EN ISO 13485:2016/AC:2018

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

General information

60.60 Standard published   Mar 28, 2018

CEN/CENELEC

CEN/CLC/JTC 3 Quality management and corresponding general aspects for medical devices

European Norm

03.100.70   Management systems | 11.040.01   Medical equipment in general

Related legislation

Legislation related to this standard

90/385/EEC

Active implantable medical devices

Harmonized/Supporting
93/42/EEC

Medical devices

Harmonized/Supporting
98/79/EC

In vitro diagnostic medical devices

Harmonized/Supporting
2017/746

Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU

Harmonized/Supporting
2017/745

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

Harmonized/Supporting

Life cycle

PREVIOUSLY

Corrects
EN ISO 13485:2016

Replaces
EN ISO 13485:2016/AC:2016

NOW

PUBLISHED
EN ISO 13485:2016/AC:2018
60.60 Standard published
Mar 28, 2018